Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen (ORT-OXI-2009)

Hospital Universitario de Canarias

Status and phase: Unknown; Phase 2

Conditions: Fibrosis

Treatments: Drug: pentoxifylline with tocopherol; Other: pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01822405

ORT-OXI-2009

Details and patient eligibility

About

The pentoxifylline used with tocopherol achieves a certain effectiveness in the treatment of the fibrosis.

Hyperbaric oxygen therapy has been recommended and used in a wide variety of medical conditions including the treatment of delayed radiation injuries (soft tissue and bony radiation necrosis). The hyperbaric oxygen therapy increases the formation of granulation tissue and produces angiogenesis maintained after use.

Full description

Patients with head and neck tumors often present superficial radiation induced fibrosis and other late complications of radiotherapy that can seriously affect their quality of life.

The pentoxifylline used with tocopherol achieves a certain effectiveness in the treatment of the fibrosis.

Hyperbaric oxygen therapy has been recommended and used in a wide variety of medical conditions including the treatment of delayed radiation injuries (soft tissue and bony radiation necrosis). The hyperbaric oxygen therapy increases the formation of granulation tissue and produces angiogenesis maintained after use.

Both treatments in combination could produce a synergistic effect because the angiogenesis induced by hyperbaric oxygen therapy allow better access to drugs to the injury. The magnetic resonance, provides data of the fibrosis and other side effects of radiotherapy.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Over 18 years and under 70 years old.
2. Patients who have received radiotherapy after being diagnosed with cancer of upper aerodigestive tract, and have skin toxicity grade II or higher.
3. Follow-up for at least a year after the radiation treatment is completed.
4. Absence of tumor at the time of recruitment.
5. Patients with the capacity to give informed consent

Exclusion criteria

1. Allergy or hypersensitivity to Pentoxifylline or others xanthines, or to Tocopherol (vitamin E).
2. Patients taking oral anticoagulants (acenocoumarol, warfarin).
3. Known hemorrhagic/coagulation disorder.
4. Vitamin K deficiency due to any cause.
5. Use of estrogens oral contraceptives.
6. Serious bleeding or extensive retinal hemorrhage.
7. Ischaemic heart diseases, including recent Myocardial Infarction.
8. Serious cardiac arrhythmia.
9. Severe liver disease.
10. Severe renal failure (creatinine clearance <30 mL/min).
11. Hypotension.
12. Patients with metal objects or electronic devices such as cardiac pacemakers, artificial heart valves or cochlear implants, or any other contraindication for MRI
13. Contraindication for Hyperbaric oxygen therapy.
14. Patients with mobility problems.
15. Female patients who are pregnant or lactating
16. Any other situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Pentoxifylline + Tocopherol

Active Comparator group

Description:

Pentoxifylline 800 mg/day (400 mg/12hours) + Tocopherol 1000 mg/day oral during 6 months

Treatment:

Drug: pentoxifylline with tocopherol

pentoxifylline + tocopherol + Hyperbaric Oxygen Therapy

Experimental group

Treatment:

Other: pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy